Major 44-112

Drug Facts

Composition & Product

Active Ingredients

Pseudoephedrine (30 mg)

Inactive Ingredients

Croscarmellose Sodium Fd&c Yellow No. 6 Hypromellose, Unspecified Magnesium Stearate Polydextrose Polyethylene Glycol, Unspecified Titanium Dioxide Triacetin Dibasic Calcium Phosphate Dihydrate Fd&c Red No. 40 Microcrystalline Cellulose Silicon Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 44;112 Shape: round Color: red Size: 7 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 1981-08-25

Medication Information

Purpose

Nasal decongestant

How Supplied

Product: 50090-0157

NDC: 50090-0157-1 24 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON

NDC: 50090-0157-3 30 TABLET, FILM COATED in a BOTTLE

NDC: 50090-0157-0 24 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON

Description

Pseudoephedrine HCl 30 mg

Uses

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves sinus congestion and pressure

Directions

adults and children 12 years and over	take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours
children ages 6 to 11 years	take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours
children under 6 years	do not use

Do Not Use

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Other Information

each tablet contains: calcium 15 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Pseudoephedrine Hcl

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin

Questions Or Comments?

(800) 616-2471

When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with fever

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Pseudoephedrine HCl 30 mg

Ask A Doctor Before Use If You Have

heart disease
diabetes
thyroid disease
high blood pressure
difficulty in urination due to enlargement of the prostate gland

Structured Label Content

Uses

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves sinus congestion and pressure

Purpose

Nasal decongestant

Directions

adults and children 12 years and over	take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours
children ages 6 to 11 years	take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours
children under 6 years	do not use

Do Not Use (Do not use)

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

How Supplied (HOW SUPPLIED)

Product: 50090-0157

NDC: 50090-0157-1 24 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON

NDC: 50090-0157-3 30 TABLET, FILM COATED in a BOTTLE

NDC: 50090-0157-0 24 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON

Other Information (Other information)

each tablet contains: calcium 15 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Pseudoephedrine Hcl (Pseudoephedrine HCl)

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin

Questions Or Comments? (Questions or comments?)

(800) 616-2471

When Using This Product (When using this product)

do not exceed recommended dosage.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with fever

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Pseudoephedrine HCl 30 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

heart disease
diabetes
thyroid disease
high blood pressure
difficulty in urination due to enlargement of the prostate gland

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure", "Purpose": "Nasal decongestant", "Directions": "adults and children 12 years and over take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours children ages 6 to 11 years take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours children under 6 years do not use", "Do not use": "if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.", "HOW SUPPLIED": "Product: 50090-0157 NDC: 50090-0157-1 24 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON NDC: 50090-0157-3 30 TABLET, FILM COATED in a BOTTLE NDC: 50090-0157-0 24 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON", "Other information": "each tablet contains: calcium 15 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number", "Inactive ingredients": "croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin", "Questions or comments?": "(800) 616-2471", "When using this product": "do not exceed recommended dosage.", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever", "If pregnant or breast-feeding,": "ask a health professional before use. ", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "Active ingredient (in each tablet)": "Pseudoephedrine HCl 30 mg", "Ask a doctor before use if you have": "heart disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information